Clinical trial · Observational
Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery
Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery: Efficacy, Safety, and Discharge Times
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Spinal anesthesia for anorectal surgery ( fistulotomy, fissure repair, pilonidal sinus excision,hemorrhoidectomy..) is a popular and widely used method characterized by rapid onset, delivery, easy mobilization and short hospital history. In order to minimize complications after spinal anesthesia, the use of lower-dose local anesthesia with the saddle block method has recently become widespread. Bupivacaine is often used for this method. Bupivacaine can be used hypobaric or hyperbaric in spinal anesthesia. Early mobilization and early discharge are important and necessary in an anorectal disease group that has such a high incidence and does not require rapid surgery and postoperative follow-up and hospitalization.Outpatient surgery is a very suitable surgical procedure for anorectal surgeries. In the light of all this information, the aim of this study is to evaluate and observe the hemodynamic data, bromage scores, mobilization and discharge of patients who underwent spinal anesthesia with two different techniques.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Fissures | — | UNRESOLVED | — |
| Anal Polyp | — | UNRESOLVED | — |
| Anorectal Diseases | — | UNRESOLVED | — |
| Hemorrhoids | — | UNRESOLVED | — |
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| use of different spinal anesthesia techniques | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Discharge Time
- timeFrame
- 1 day after surgery
- description
- to determine the time at which patients are ready for discharge
Secondary outcomes (12)
- measure
- Modified Bromage Scale
- timeFrame
- 5 minutes after spinal anesthesia End of the surgery (up to 1 hour) Postoperative 15 minutes Postoperative 30 minutes Postoperative 45 minutes Postoperative 60 minutes
- description
- to determine the amount of motor function
- measure
- Time Of First Analgesic Need
- timeFrame
- 1 day after surgery
- description
- to measure when the pain started
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Both sexes undergoing anorectal surgery, 18-65 years old, ASA score 1-2 patients Exclusion Criteria: * be under the age of 18 * be over 65 * ASA score of 3 and greater than 3 * patients with fever * those who are pregnant * Patients with kidney failure * Patients with hepatic insufficiency * Patients with heart failure * Patients with upper respiratory tract symptoms * Patients with coagulation disorders * Patients with infection in the lumbar region * Patients with BMI \<18 and BMI \>40 * Patients with uncontrolled hypertension, diabetes, pheochromocytoma and thyroid dysfunction * Those who do not have the ability to read, write or understand the consent form * Patients who do not want to sign the consent form * Patients deemed unsuitable by the investigator
References
Publications (2)
- BACKGROUNDHonca M, Dereli N, Kose EA, Honca T, Kutuk S, Unal SS, Horasanli E. Low-dose levobupivacaine plus fentanyl combination for spinal anesthesia in anorectal surgery. Braz J Anesthesiol. 2015 Nov-Dec;65(6):461-5. doi: 10.1016/j.bjane.2014.01.007. Epub 2014 Feb 20. PMID 26614142
- BACKGROUNDTaspinar V, Sahin A, Donmez NF, Pala Y, Selcuk A, Ozcan M, Dikmen B. Low-dose ropivacaine or levobupivacaine walking spinal anesthesia in ambulatory inguinal herniorrhaphy. J Anesth. 2011 Apr;25(2):219-24. doi: 10.1007/s00540-010-1089-9. Epub 2011 Jan 12. PMID 21225292